Research and Development

Biocompatibility & Toxicological Expert (m/f/d)

Address:

  • Frankfurter Str. 6-8, St. Wendel, SL 66606, Germany
  • Else-Kröner Str. 1, Bad Homburg, HE 61352, Germany

Job ID: R0172154

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As a Clinic Manager at Fresenius Medical Care, you’ll manage the daily operations of our outpatient centers. More importantly, you’ll be the key driver in carrying out our mission: To deliver superior care that improves the quality of life of every patient, every day, setting the standard by which others in the health care industry are judged. This is accomplished by hiring, developing and inspiring a multi-disciplinary team, collaborating with physicians, tracking and delivering superior patient outcomes and monitoring regulatory and safety requirements. Strong management skills are required and prior direct patient care experience is needed for occasions when the team needs a helping hand.

A female nurse examining her patient

Patient Care Technicians (PCTs) at Fresenius Medical Care support and collaborate with RNs to provide dialysis treatment to several patients at a time while maintaining the functionality of the clinic. This involves prepping and testing equipment, reviewing treatment sheets, and opening the clinic at 4am for first shift. PCTs have a combination of technical skills and genuine passion needed to develop deep relationships with patients and improve their quality of life. Qualified candidates have prior customer service, healthcare and direct patient care experience, and will have the opportunity to learn the discipline of dialysis.

A female nurse examining her patient

Fresenius Medical Care nurses are on the front line of patient care, improving the quality of life of every patient, every day. That means providing dialysis care to 10-12 patients at any given time, and collaborating with our multi-disciplinary team to deliver a unique care plan to each one of them. This role is all about relationships and the bond you’ll create with patients and their families. Prior dialysis nursing experience is helpful, but many successful candidates come from a background in ICU, PCU and/or surgery.

A female nurse examining her patient

Job Description

In Ihrer Rolle als Biocompatibility & Toxicological Expert (m/w/d) sind Sie Partner von Produktentwicklungsteams, um sicherzustellen, dass konforme und sichere Produkte in Bezug auf Biokompatibilität und Toxikologie gewährleistet werden.

Ihre Aufgaben

  • Bewertung der Biokompatibilität von Medizinprodukten im Rahmen der Verordnung (EU) 2017/745 über Medizinprodukte (MDR), der ISO 10993-Serie und anderer regulatorischer Richtlinien/Anforderungen
  • Definition von Biokompatibilitätsbewertungsstrategien für Design- und Entwicklungsprojekte Experte in funktionsübergreifenden Teams zu Fragen der Materialkonformität und Biokompatibilität
  • Durchführung von Sicherheits- und Risikobewertungen für Medizinprodukte auf der Grundlage der verwendeten Rohstoffe, auf extrahierbaren und auslaugbaren Chemikalien oder auf der Grundlage von Biokompatibilitätsstudien (ISO 10993-17)
  • Kompetente Beratung Als Sponsor, Studienmonitor und Ansprechpartner für chemische/Biokompatibilitätsstudien in internen und externen Laboratorien
  • Erstellung einer allgemeinen biologischen Sicherheitsbewertung nach ISO 10993-1

Ihr Profil

  • Erfolgreich abgeschlossenes Bachelor- oder Masterstudium in Natur- oder Ingenieurwissenschaften oder einem ähnlichen technischen Bereich erforderlich, wie z.B. Medizintechnik
  • Mehrjährige einschlägige Berufserfahrung oder ein höherwertiger Abschluss ohne Erfahrung oder gleichwertige direkt damit zusammenhängende Berufserfahrung
  • Erfahrung in der Erstellung von Biokompatibilitätsbewertungen und toxikologischen Gutachten Anwendung von Designkontrolle und Risikomanagement sowie Kenntnisse und Vertrautheit mit den Konzepten von FDA CFR 820, ISO13485, IEC 60601 und ISO 14971
  • Kenntnisse im Risikomanagement von Medizinprodukten und den damit verbundenen Vorschriften
  • Kenntnisse in der Biokompatibilitätsprüfung von Medizinprodukten nach ISO 10993
  • Fähigkeit, technische Informationen an ein nicht-technisches Publikum zu vermitteln
  • Sehr gute Präsentations- und Kommunikationsfähigkeiten
  • Fließende Deutsch- und Englischkenntnisse in Wort und Schrift

Success Profile

What makes a successful member of our team? Check out the top traits we are looking for and see if you have the right mix.

Success profile proportion

Success Profile

What makes a successful member of our team? Check out the top traits we are looking for and see if you have the right mix.

Success profile proportion

Success Profile

What makes a successful member of our team? Check out the top traits we are looking for and see if you have the right mix.

Success profile proportion
“You have a lot of independence...so the doctors trust you. You have to be able to make decisions on your own.”
Lesly,
Inpatient Services RN

We've got your back.

We fully believe that dedication and passion should be recognized and rewarded. That’s why we offer a competitive compensation and benefits package to all of our employees. Our benefits provide the flexibility, choice and support you need to be at your best as you play a vital part in helping patients live longer, better and healthier lives.

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